Public support for and concerns regarding pediatric dose optimization for seizures in emergency medical services: An exception from informed consent (EFIC) trial.

BACKGROUND: Federal regulations allow exception from informed consent (EFIC) to study emergent conditions when obtaining prospective consent is not feasible. Little is known about public views on including children in EFIC studies. The Pediatric Dose Optimization for Seizures in EMS (PediDOSE) trial implements age-based, standardized midazolam dosing for pediatric seizures. The primary objective of this study was to determine public support for and concerns about the PediDOSE EFIC trial. The secondary objective was to assess how support for PediDOSE varied by demographics. METHODS: We conducted a mixed-methods study in 20 U.S. communities. Participants reviewed information about PediDOSE before completing an online survey. Descriptive data were generated. Univariable and multivariable logistic regression analysis identified factors associated with support for PediDOSE. Reviewers identified themes from free-text response data regarding participant concerns. RESULTS: Of 2450 respondents, 79% were parents/guardians, and 20% had a child with previous seizures. A total of 96% of respondents supported PediDOSE being conducted, and 70% approved of children being enrolled without prior consent. Non-Hispanic Black respondents were less likely than non-Hispanic White respondents to support PediDOSE with an adjusted odds ratio (aOR) of 0.57 (95% CI 0.42-0.75). Health care providers were more likely to support PediDOSE, with strongest support among prehospital emergency medicine clinicians (aOR 5.82, 95% CI 3.19-10.62). Age, gender, parental status, and level of education were not associated with support of PediDOSE. Common concerns about PediDOSE included adverse effects, legal and ethical concerns about enrolling without consent, and potential racial bias. CONCLUSIONS: In communities where this study will occur, most respondents supported PediDOSE being conducted with EFIC and most approved of children being enrolled without prior consent. Support was lowest among non-Hispanic Black respondents and highest among health care providers. Further research is needed to determine optimal ways to address the concerns of specific racial and ethnic groups when conducting EFIC trials.

Enroller Experience and Parental Familiarity of Disease Influence Participation in a Pediatric Trial.

INTRODUCTION: Acquiring parental consent is critical to pediatric clinical research, especially in interventional trials. In this study we investigated demographic, clinical, and environmental factors associated with likelihood of parental permission for enrollment in a study of therapies for diabetic ketoacidosis (DKA) in children. METHODS: We analyzed data from patients and parents who were approached for enrollment in the Pediatric Emergency Care Applied Research Network (PECARN) Fluid Therapies Under Investigation in DKA (FLUID) trial at one major participating center. We determined the influence of various factors on patient enrollment, including gender, age, distance from home to hospital, insurance status, known vs new onset of diabetes, glycemic control (hemoglobin A1c), DKA severity, gender of the enroller, experience of the enroller, and time of enrollment. Patients whose parents consented to participate were compared to those who declined participation using bivariable and multivariable analyses controlling for the enroller. RESULTS: A total of 250 patient/parent dyads were approached; 177 (71%) agreed to participate, and 73 (29%) declined. Parents of patients with previous episodes of DKA agreed to enroll more frequently than those with a first DKA episode (94.3% for patients with 1-2 previous DKA episodes, 92.3% for > 2 previous episodes, vs 64.9% for new onset diabetes and 63.2% previously diagnosed but no previous DKA). Participation was also more likely with more experienced enrollers (odds ratio [95% confidence interval] of participation for an enroller with more than two years' experience vs less than two years: 2.46 [1.53, 3.97]). After adjusting for demographic and clinical factors, significant associations between participation and both DKA history and enroller experience remained. Patient age, gender, distance of home from hospital, glycemic control, insurance status, and measures of DKA severity were not associated with likelihood of participation. CONCLUSION: Familiarity with the disease process (previously diagnosed diabetes and previous experience with DKA) and experience of the enroller favorably influenced the likelihood of parental permission for enrollment in a study of DKA in children.

Consequences of pediatric undertriage and overtriage in a statewide trauma system.

BACKGROUND: With increasing attention to the quality of health care delivery, evaluating trauma triage decisions in a large system of emergency care can help decision makers reduce mortality, morbidity, unnecessary transfers, and health care costs. OBJECTIVES: To quantify the magnitude of pediatric traumatic injury undertriage (hospital mortality risk) and overtriage (early trauma center discharge after transfer) in a statewide trauma system. METHODS: A statewide population-based evaluation of pediatric trauma outcomes and secondary triage (interfacility transfers) patterns from 2001 to 2013 among 45 hospitals in Utah's statewide trauma system. RESULTS: The odds of pediatric transfer were 13 times lower (odds ratio, 13.15; p < 0.0001; 95% confidence interval, 11.0-15.7) in acute care hospitals meeting undertriage criteria than hospitals meeting overtriage criteria. Hospital triage practice was a stronger predictor of pediatric transfer than injury severity, injury diagnoses, age, and geographic distance. The likelihood of pediatric trauma mortality was more than twice higher in undertriage hospitals than overtriage hospitals (OR, 2.44; p < 0.0001; 95% confidence interval, 1.5-3.8). Among pediatric patients that survived the injury to transfer, 61% were discharged from the pediatric center in < 24 hours. CONCLUSION: Substantial opportunity exists in the state trauma system to improve pediatric trauma patient transfer practices to reduce pediatric trauma mortality, morbidity, and health care costs associated with unnecessary transfers. LEVEL OF EVIDENCE: Prognostic and epidemiological, level III.

Relative productivity of nurse practitioner and resident physician care models in the pediatric emergency department.

OBJECTIVES: Duty hour restrictions limit the use of resident physicians in pediatric emergency departments (PEDs). We sought to determine the relative clinical productivity of PED attending physicians working with residents compared with PED attending physicians working with nurse practitioners (NPs). METHODS: In a tertiary care PED with multiple care models (PED attending physicians with residents and/or fellows, PED attending physicians with NPs, PED attending physicians alone), we identified periods when care was provided concurrently and exclusively by a PED attending physician with 1 to 2 residents (resident pod) and a PED attending physician with 1 NP (NP pod). Billing records were reviewed to determine relative value units (RVUs) generated and patients seen by each PED attending physician. Emergency Severity Index (ESI) triage scores were used to compare patient acuities. RESULTS: The NP pods generated 5.35 RVUs per hour and the resident pods generated 4.35 RVUs per hour, with a significant difference of 1.00 RVUs per hour (95% confidence interval, 0.19-1.82). The NP pods saw 2.18 patients per hour, whereas the resident pods saw 1.90 patients per hour. This difference of 0.28 was not statistically significant (95% confidence interval, -0.07 to 0.62). Patient acuity was similar. Thirteen percent of the NP pod patients had the highest triage severity levels of ESI-1 and ESI-2, whereas 19% of the resident pod patients were ESI-1 and ESI-2 (P = 0.06). CONCLUSIONS: Pediatric emergency department attending physicians in an NP care model had greater clinical productivity, measured by RVUs, than PED attending physicians in a resident care model while treating similar patient populations.

Variation of community consultation and public disclosure for a pediatric multi-centered "Exception from Informed Consent" trial.

BACKGROUND: The US federal regulation "Exception from Informed Consent for Emergency Research," 21 Code of Federal Regulations 50.24, permits emergency research without informed consent under limited conditions. Additional safeguards to protect human subjects include requirements for community consultation and public disclosure prior to starting the research. Because the regulations are vague about these requirements, Institutional Review Boards determine the adequacy of these activities at a local level. Thus, there is potential for broad interpretation and practice variation. AIM: To describe the variation of community consultation and public disclosure activities approved by Institutional Review Boards, and the effectiveness of this process for a multi-center, Exception from Informed Consent, pediatric status epilepticus clinical research trial. METHODS: Community consultation and public disclosure activities were analyzed for each of the 15 participating sites. Surveys were conducted with participants enrolled in the status epilepticus trial to assess the effectiveness of public disclosure dissemination prior to study enrollment. RESULTS: Every Institutional Review Board, among the 15 participating sites, had a varied interpretation of Exception from Informed Consent regulations for community consultation and public disclosure activities. Institutional Review Boards required various combinations of focus groups, interviews, surveys, and meetings for community consultation, and news releases, mailings, and public service announcements for public disclosure. At least 4335 patients received information about the study from these efforts. In all, 158 chose to be included in the "Opt Out" list. Of the 304 participants who were enrolled under Exception from Informed Consent, 12 (5%) had heard about the study through community consultation or public disclosure activities. The activities reaching the highest number of participants were surveys and focus groups associated with existing meetings. Public disclosure activities were more efficient and cost-effective if they were part of an in-hospital resource for patients and families. CONCLUSION: There is substantial variation in Institutional Review Boards' interpretations of the federal regulations for community consultation and public disclosure. One of the goals of community consultation and public disclosure efforts for emergency research is to provide community members an opportunity to opt out of Exception from Informed Consent research; however, rarely do patients or their legally authorized representatives report having learned about a study prior to enrollment.

Developing future clinician scientists while supporting a research infrastructure.

BACKGROUND: Supporting clinical research is a national priority. Clinician scientists are rare and clinical trials in academic medical centers (AMC) often fail to meet enrollment goals. Undergraduate students interested in biomedical careers often lack opportunities to perform clinical research. OBJECTIVE: Describe an innovative undergraduate course that supports clinical research in an AMC. METHODS: The course, Clinical Research Methods and Practice, offers undergraduate students the opportunity to learn clinical research through didactic and practical experiences. The students in turn support clinician scientists' conduct of clinical studies in an AMC. Clinician scientists receive research support and participate in mentoring sessions for students. RESULTS: Over seven semesters, 128 students have assisted in 21 clinical studies located in outpatient and inpatient units of two hospitals. Students identified and screened eligible patients, collected clinical data, assisted in obtaining informed consent, and transported specimens. Many of the clinician scientists have met their enrollment goals and several have been top-enrollers in multicenter clinical trials as a result of student support. CONCLUSIONS: The Clinical Research Methods and Practice class addresses barriers to clinical research in AMC. This may be a model for institutions committed to mentoring students early in their career and to developing infrastructures for clinical research.